Clearance Summary
CanMINI Hand and Foot System received FDA 510(k) clearance under submission number K242973, sponsored by Canwell Medical Co., Ltd.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2025-04-24.
- Submission: K242973
- Applicant / Sponsor: Canwell Medical Co., Ltd.
- Clearance pathway: Abbreviated
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3030
- Decision date: 2025-04-24
Classification & Regulation
This clearance is catalogued under FDA product code HRS and 21 CFR 888.3030, within the Orthopedic review panel as a Class II device.